This study is a prospective, single-arm, single-center, phase II study. The goal of this clinical trial is to explore the therapeutic value of the treatment model of "tislelizumab combined with chemotherapy followed by radiotherapy/adaptive surgery" on larynx Preservation of locally advanced hypopharyngeal cancer and laryngeal cancer.
Historical studies have shown that induction chemotherapy can provide an opportunity to preserve the larynx in approximately 60-70% of patients with locally advanced laryngeal/hypopharynx carcinoma. Recently, phase I-II clinical studies have shown that induction of PD-1 inhibitors has a good pathological response in locally advanced head and neck cancer, with or without combined chemotherapy. However,the primary lesion and lymph nodes respond asynchronously or even in the opposite way to immune induction therapy. The primary lesion is more likely to achieve CR/PR, while the lymph nodes are more likely to show PR/SD or even PD. Therefore, the surgical or radiotherapy plan should be implemented according to the specific response of the primary lesion and metastatic lymph nodes to induction therapy. This study aimed to determine whether the combination of induction chemotherapy with a PD-1 inhibitor (Tislelizumab) followed by chemoradiotherapy or adaptive surgery can improve the rate of laryngeal preservation in patients with resectable laryngeal/hypopharynx cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Induction chemotherapy TP regimen combined with Tislelizumab for 3 cycles: Cisplatin 37.5mg/m2 d1-2 q3w, Docetaxel 37.5mg/m2 d1and d3 q3w,Tislelizumab 200mg d3 q3w. •Response rate of primary tumor or lymph nodes is evaluated using laryngoscopy and head and neck MRI after 3 cycles of induction therapy. If the primary lesion reaches CR/PR and the lymph nodes reach CR, chemoradiotherapy based on cisplatin is conducted. If the primary lesion reaches CR/PR and lymph node PR/PD, cervical lymph node dissection will be performed, followed by radiotherapy/concurrent chemoradiotherapy. If the primary lesion is SD/PD, regardless of the condition of the lymph nodes, primary lesion resection and lymph node dissection should be performed, followed by adjuvant radiation/chemoradiation. Other Names: Docetaxel Cisplatin Paclitaxel
Henan Cancer Hospital
Zhengzhou, Henan, China
Laryngeal preservation rate at 3 months after radiotherapy
defined as the absence of any residual disease that would justify salvage total laryngectomy
Time frame: 3-month post-radiotherapy
Objective response rate after induction chemoimmunotherapy
2 weeks after the 3th cycle of induction therapy
Time frame: 2 weeks after the end of cycle 3 of induction therapy
Overall survival rate at 1 year
Overall survival rate at 1 year
Time frame: One year post-radiotherapy
Laryngeal preservation rate at 1 year after radiotherapy
defined as the absence of any residual disease that would justify salvage total laryngectomy
Time frame: 1 year post-radiotherapy
Progression-free survival rate at 1 year
Progression-free survival rate at 1 year
Time frame: One year post-radiotherapy
Pathological complete response rate of the patients receiving surgical resection
Pathological complete response rate of the patients receiving surgical resection, evaluated by experienced pathologists
Time frame: Within 3 weeks after surgery
Overall survival rate at 2 year
Overall survival rate at 2 year
Time frame: Two year post-radiotherapy
Progression-free survival rate at 2 year
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Progression-free survival rate at 2 year
Time frame: Two year post-radiotherapy
Laryngeal Preservation rate at 2 year
Two year post-radiotherapy
Time frame: Laryngeal Preservation rate at 2 year
Adverse Effect
Adverse Effect, evaluated by CTCAE 4.0.03
Time frame: One year post-radiotherapy
Major pathologic response rate of the patients receiving surgical resection
Major pathologic response rate, defined as no more than 10% of residual viable tumor, evaluated by experienced pathologists
Time frame: Within 3 weeks after surgery